Post-Market Clinical Data Analysis With Skanrays Defibrillators (Clinical study to record the safety and performance data of Skanrays Defibrillators in real world scenario)
- Conditions
- Health Condition 1: R001- Bradycardia, unspecifiedHealth Condition 2: I468- Cardiac arrest due to other underlying conditionHealth Condition 3: I462- Cardiac arrest due to underlying cardiac conditionHealth Condition 4: I469- Cardiac arrest, cause unspecifiedHealth Condition 5: I482- Chronic atrial fibrillationHealth Condition 6: I480- Paroxysmal atrial fibrillationHealth Condition 7: I481- Persistent atrial fibrillationHealth Condition 8: I489- Unspecified atrial fibrillation and atrial flutter
- Registration Number
- CTRI/2023/05/053279
- Lead Sponsor
- Skanray Technologies Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
Data from the subject that meets the below-mentioned criteria shall be collected.
? Patients with indications for defibrillation/cardioversion/pacing.
? Male and female subjects who weigh above 10 kg.
? Unsafe conditions or surroundings for the use of Direct Current
? Contraindications for defibrillation
A A responsive patient with spontaneous breathing and a palpable pulse.
B Asystole or pulseless electrical activity PEA
? Contraindications for cardioversion - arrhythmias due to enhanced automaticity, such as
digitalis toxicity of digitalis-associated tachycardia, sinus tachycardia, multifocal atrial
tachycardia and junctional tachycardia. Catecholamine-induced arrhythmia having a
homogeneous depolarization state Eg CPVT, shall be excluded.
? Contraindications for pacing - asymptomatic subjects with a reasonably stable rhythm.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method